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Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke (E-COMPASS)

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ClinicalTrials.gov Identifier: NCT01996761
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
Yun-Hee Kim, Samsung Medical Center

Brief Summary:
This study, E-COMPASS is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 75 subacute stroke patients with unilateral motor dysfunction. Primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of FMA at baseline) in patients with subacute stroke.

Condition or disease Intervention/treatment Phase
Cerebrolysin Drug: porcine brain peptide (Cerebrolysin) Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke
Study Start Date : January 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : February 2014

Arm Intervention/treatment
Experimental: Study Group 1
Study Group 1: 30ml Cerebrolysin
Drug: porcine brain peptide (Cerebrolysin)
Placebo Comparator: Study Group 2
Study Group 2: Placebo (0.9% NaCl)
Drug: Placebo



Primary Outcome Measures :
  1. the improvement ratio of Fugl-Meyer assessment [ Time Frame: after 3 weeks ]
    Primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of FMA at baseline) in patients with subacute stroke



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 1st cortical or subcortical unilateral infarction (supratentorial lesion)
  2. Confirmed by CT or MRI
  3. Subacute stage: less than 1 week
  4. Moderate to severe motor function involvement-total of FMA: 0-84
  5. Age: between 18 and 80 years
  6. Inpatients

Exclusion Criteria:

  1. Progressive or unstable stroke
  2. Pre-existing and active major neurological disease
  3. Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
  4. A history of significant alcohol or drug abuse in the prior 3 years
  5. Advanced liver, kidney, cardiac, or pulmonary disease
  6. A terminal medical diagnosis consistent with survival < 1 year
  7. Substantial decrease in alertness at the time of randomization, defined as score of 2 on NIH Stroke Scale
  8. Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
  9. Any condition that would represent a contraindication to Cerebrolysin, including allergy to Cerebrolysin
  10. Current enrolment in another therapeutic study of stroke or stroke recovery
  11. Total serum bilirubin > 4 mg/dL, alkaline phosphatase > 250 U/L, SGOT/AST > 150 U/L, SGPT/ALT > 150 U/L, or creatinine > 3.5 mg/dL; or cardiopulmonary deficits large enough to interfere with reasonable participation in physiotherapy during the trial.
  12. Previous porcine brain peptide administration history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996761


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yun-Hee Kim, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01996761     History of Changes
Other Study ID Numbers: 2010-09-084-001
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Cerebrolysin
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Nootropic Agents